Influenza H1N1 (swine flu) vaccination: a safety surveillance feasibility study using self-reporting of serious adverse events and pregnancy outcomes

Isla S Mackenzie, Thomas M Macdonald, Saad Shakir, Moira Dryburgh, Brian J Mantay, Patrick McDonnell, Deborah Layton

    Research output: Contribution to journalArticlepeer-review

    32 Citations (Scopus)

    Abstract

    WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • While the new H1N1 vaccines underwent the usual rigorous safety and efficacy testing, concerns remained that there may be unexpected side effects of the vaccines. • The strategy for H1N1 vaccine pharmacovigilance in the UK consisted of two patient studies by the two vaccine manufacturers, 14 small scale studies supported by the National Institute of Health Research, monitoring by specialist neurologists and the MHRA. • There were calls to investigate the feasibility of a large-scale prospective active surveillance system for 'near real-time' vaccine safety monitoring that would be complementary to the other aforementioned initiatives. WHAT THIS STUDY ADDS • This pilot study demonstrated that collecting 'near real-time' reporting of event data from patients who experienced side effects as well as those who reported no problems after swine flu vaccination is feasible. • The use of information technologies improves patient involvement in research as well as dramatically limiting the cost of the study. • The online methodology facilitates rapid surveillance in response to urgent safety issues.
    Original languageEnglish
    Pages (from-to)801-811
    Number of pages11
    JournalBritish Journal of Clinical Pharmacology
    Volume73
    Issue number5
    DOIs
    Publication statusPublished - 2012

    Keywords

    • H1N1 vaccination
    • GUILLAIN-BARRE-SYNDROME
    • safety surveillance
    • IMMUNIZATION
    • VIRUS
    • post marketing

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